-Helping the poor who do not have money to attend treatment.
The goal is to reduce the incidence of chronic hepatitis B; reduced
rates of cirrhosis and hepatocellular carcinoma due to hepatitis B;
hepatitis C worldwide.
the burden of health costs for society.
to drugs available on the market with the lowest cost.
- ClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt
Date: April 24, 2020
Protocol ID: HBsAg 07-10 - SAIGON BIOPHARMA COMPANY LIMITID
Brief Title: Treatment on HBeAg Positive or HBeAg Negative in Chronic Hepatitis B ( HBV )
Official Title: Tenofovir Disoproxil Fumarate - Phyllanthus Urinaria - Adenosmatis
- Eclipta Prostrata, Ascorbic Acid daily is
in the Long-term Treatment of Chronic and Acute Hepatitis B.
Verification: April 2020
Access Status: Approved for marketing
Triệu, Nguyễn Thị, M.D.
Triệu, Nguyễn Thị, M.D. [trieut]
Title: Trần Minh Đức
Triệu, Nguyễn Thị, M.D.
U.S. FDA IND/IDE: No
Summary: Phyllanthus Urinaria - Adenosma Glutinosum - Eclipta
Prostrata - Ascorbic
combination plus Tenofovir in the treatment of acute and chronic
Method the combination of drugs derived from natural and artificial medicaments.
has a stronger effect on the immune system, effective good against
is a substantial new insight into the pathogenesis of the disease,
with a clear path toward clinical application, or which would lead to
a substantial advance and
perfect in management or public health policy.
Description: Recent studies have proved Phyllanthus Urinaria -
Eclipta Prostrata - Ascorbic Acid combination plus Tenofovir in the
treatment of acute and chronic hepatitis B. Method the combination of
drugs derived from
natural and artificial medicaments. To make clean jobs for HBV - DNA in the
body - hope this is a new step of medicine, will no longer exist
HBV infection " Methods of safety, therapeutic effect on the
expected cost savings should easily apply to everyone everywhere in
the world. According to the investigation and must be called, Chronic
HBV infection is an important worldwide cause of morbidity,
mortality, and source of potential new infections. There are an
estimated 350 million carriers of HBV in the world. In China,
Southeast Asia, and sub-Saharan Africa, as many as 10-15% of the
chronically infected. In North America and Northern Europe, infection
rates are much lower, usually below 1%. Intermediate carrier rates of
are found in Southern Europe (e.g., Italy, Greece, and Spain), parts
and Central America, the Middle East, and Japan. Persistent infection
in over 90% of perinatally infected children and 3-10% of people
become infected after the age of 6 years. Worldwide, it has been
more than one million people die annually due to HBV-related end
such as cirrhosis and hepatocellular carcinoma.
goal of antiviral therapy for hepatitis B is to reduce a patient's
liver disease through prolonged suppression and eradication of
infection and to arrest or ameliorate HBV-related liver damage.
CHRONIC HEPATITIS B
Type: Expanded Access
Drug: CTH Chronic Hepatitis B
Age: 18 Years
Age: 60 Years
and females ≥ 18 years of age with chronic and acute hepatitis B.
• Hepatitis B surface antigen (HBsAg)(+) for a minimum of 6 months before entry.
B envelope antigen (HBeAg)(+) or (-) at baseline.
having treated or untreated
with compensated liver function (Child-Pugh score ≤ 6).
• Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol. or cytokine-based therapies with possible activity in hepatitis B disease within 6 months before study screening.
or bone marrow transplant recipients.
of active liver disease to operate.
immunoglobulins, interferon or other immune e to other causes
(e.g., Wilson's disease, hemochromatosis, autoimmune hepatitis, hepatitis C, hepatitis D or HIV.)
• Patients taking parenteral (intravenous or intramuscular or subcutaneous) or oral steroids, immuno-suppressant therapies or chemotherapeutic agents within 2 months of study screening or expected to receive these agents during the study.
• Clinically relevant alcohol or drug use or history of alcohol or drug use considered by the investigator to be sufficient to hinder compliance with treatment, follow up procedures or evaluation of adverse events.
concurrent medical illness is other than hepatitis B.
of hypersensitivity to nucleoside analogs.
of childbearing potential not practicing adequate contraception.
Contact Person: Nguyễn Thị Triệu, Dr.
Central Contact Backup: Trần Minh Đức, Dr.
Officials: Nguyễn Thị Triệu, Dr.
Minh Duc, Dr.
BIOPHARMA COMPANY LIMITED
Chí Minh, Ho Chi Minh City, Vietnam, 700000
Nguyễn Thị Triệu, Dr. ( 84 ) 903640722
Trần Minh Đức, Dr. ( 84 )906640722
Investigator: Nguyễn Thị Triệu, Dr.
National Library of Medicine | U.S. National Institutes of Health |
U.S. Department of Health & Human Services